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    UK Review: New Models Needed to Fight Antimicrobial Resistance

    A review of antimicrobial resistance (AMR), commissioned by the UK and led by internationally renowned economist Jim O'Neill, is calling for billions of dollars in new funding intended to incentivize drug development and head off the threat of drug-resistant disease. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World He...
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    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...
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    Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds

    The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world. Background The rise of AMR is tied to the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by antimicrobial medicin...
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    FDA Gives New Name, Authority to One of its Advisory Committees

    The US Food and Drug Administration (FDA) has formally announced it will rename its Anti-Infective Drugs Advisory Committee (AIDAC), just weeks after announcing the committee would now oversee all HIV and AIDS drugs. Background News of the change was first broken by Regulatory Focus on 20 March 2015, when we reported that FDA planned to disband its longstanding Antiviral Drugs Advisory Committee (ADAC), a committee charged with the review of new HIV and AIDS drugs. ...
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    In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

    The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals. The guideline was drafted by the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) committee, and is intended to establish standards for setting DDDA and DCDA amounts for veterinary antimicrobial products. The consultation is part of an ongoing...
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    EU Considers Major Revisions to Veterinary Medicines Regulations

    The European Parliament is considering major changes to how veterinary medical products are regulated in the EU. At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products. Background Veterinary and human medicines regulations in th...
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    EMA Releases new Policies Meant to Combat Antimicrobial Resistance

    As part of its efforts to combat antimicrobial resistance (AMR), the European Medicines Agency (EMA) has issued two draft guidelines related to the use of antimicrobial agents in veterinary medicinal products. Background Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk...
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    Three EU Agencies Collaborate on Drug Resistance Study

    Three EU agencies have announced they will work together in the hopes of better understanding one of today's most pressing global healthcare issues: Antimicrobial resistance (AMR). Global and Historical Context Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk of AMR in...
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    FDA Gonorrhea Guidance Follows Now-Familiar Framework on Antibiotic Development

    The US Food and Drug Administration (FDA) has published a new draft guidance on the development of antibacterial drugs intended to treat "uncomplicated" gonorrhea, the latest in a string of guidance documents reflecting the agency's new thinking on antibiotic development. Background In the last few years, FDA has released a bevy of guidance documents aimed at making it easier for companies to develop antibiotic products by easing requirements around clinical trials...
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    FDA Adds Three New Pathogens to GAIN Act Qualifying List, But Impact Remains Unclear

    The US Food and Drug Administration (FDA) has released an updated and final list of pathogens that are eligible for special incentives under the 2012 Generating Antibiotics Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) . Background The GAIN Act was passed in an attempt to incentivize the development of new antibiotics—a response to both growing rates of microbial resistance to antibiotics and a dearth of...
  • FDA Doubles Down on Voluntary Approach to Limiting Use of Antibiotics in Food-Producing Animals

    The US Food and Drug Administration (FDA), bowing to decades of pressure, has agreed to "significant steps" it says will limit the prescribing of antibiotics to food-producing animals in an attempt to limit the spread of antibiotic-resistant bacteria. Background FDA's antibiotic use policy first began to take shape in the 1970s, and in recent years has been subject to intense scrutiny from outside advocates , former FDA officials , government investigators , and ev...
  • FDA Proposes Making Antibiotic Monitoring Report More Useful

    Nearly five years after the passage of the Animal Drug User Fee Amendments Act (ADUFA) of 2008, the US Food and Drug Administration (FDA) is proposing to expand upon its data reporting requirements, saying companies will need to include even more data on the antimicrobial drugs they sell for use in food-producing animals. Background The policy is being advanced through proposed rulemaking released on 26 September 2013 by the agency. It was first released as a propose...